3 years relevant experience in quality engineering
Knowledge of fda regulations and iso standards
The primary purpose of this position is to perform work involving general engineering methods while utilizing advanced quality tools in the medical device industry
Job Summary
The primary purpose of this position is to perform work involving general engineering methods while utilizing advanced quality tools in the medical device industry.
You will support regulatory inspections, monitor manufacturing compliance, and ensure complete and correct Device History Records are maintained.
You are expected to lead test method validations, manage non-conforming material processes, and participate in plant CAPA activities to prevent re-occurrence.
Matching Summary
The primary purpose of this position is to perform work involving general engineering methods while utilizing advanced quality tools in the medical device industry.
Skills & Requirements
Must-have
Bachelor's degree in engineering or related field
3 years relevant experience in quality engineering
Knowledge of FDA regulations and ISO standards
Experience with QMS and Device History Records
Ability to lead root cause analysis and CAPA activities
Nice-to-have
Strong written and oral communication skills
Positive can-do attitude in high-energy environments
Experience with continuous improvement methodologies
Familiarity with Microsoft Office suite
Collaborative mindset for cross-functional teams
Key Requirements
Minimum Bachelor's degree in engineering
3+ years relevant experience (or 7+ without degree)
Awareness of Domestic and International Regulations (ISO, QSR, UL)